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Safety evaluation of self-expanding metallic biliary stents eluting gemcitabine in a porcine model

 Moon Jae Chung  ;  Hyunki Kim  ;  Kyung Sik Kim  ;  Sangsoo Park  ;  Jae Bock Chung  ;  Seung Woo Park 
 Journal of Gastroenterology and Hepatology, Vol.27(2) : 261-267, 2012 
Journal Title
 Journal of Gastroenterology and Hepatology 
Issue Date
BACKGROUND AND AIM: Palliative biliary decompression by metal stent is the treatment of choice for unresectable malignant biliary obstruction; however, conventional stents provide only mechanical palliation and exert no anti-tumor effects. Gemcitabine (GEM) has been reported to be more effective in unresectable pancreatic cancer and biliary cancer compared with other chemotherapeutic drugs. We evaluated the safety of a GEM-eluting stent by analyzing histologic responses of the porcine bile duct. METHODS: Stents containing GEM (0%, 10%, 15%, and 20% [w/v]) were surgically inserted into bile ducts of pigs (each group, n = 2). The animals were euthanized after 4 weeks, and the stented bile duct segment underwent gross and microscopic examination. Laboratory assay was performed for aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin, and gamma-glutamyl transferase (γ-GTP). RESULTS: Moderate to severe inflammation was observed in the bile ducts in contact with stents containing 15 and 20% GEM, compared with no inflammation with 0% GEM and mild inflammation with 10% GEM. Fibrous reactions observed in the submucosal layer did not differ among groups. Transmural necrosis and perforations were not observed in any animal. No abnormal laboratory test findings were directly caused by GEM. CONCLUSION: Our newly developed GEM eluting stents can be used safely in normal bile ducts. Our results indicated that 10% GEM produced mild histologic changes in the stented segment and adjacent tissue; this concentration may be appropriate for clinical application.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
Yonsei Authors
김경식(Kim, Kyung Sik) ORCID logo https://orcid.org/0000-0001-9498-284X
김현기(Kim, Hyunki) ORCID logo https://orcid.org/0000-0003-2292-5584
박승우(Park, Seung Woo) ORCID logo https://orcid.org/0000-0001-8230-964X
정문재(Chung, Moon Jae) ORCID logo https://orcid.org/0000-0002-5920-8549
정재복(Chung, Jae Bock)
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